WORLD TRADE  
ORGANIZATION  G/TBT/W/287 
6 June 2008 
 (08-2671) 
Committee on Technical Barriers to Trade  
 
 
SUMMARY REPORT OF THE  
TBT WORKSHOP ON GOOD REGULATORY PRACTICE 
18-19 MARCH 2008 
 
Note by the Secretariat1 
 
 
At the Fourth Triennial Review of the TBT Agreement, concluded in November 2006, the 
TBT Committee agreed to share experiences on a number of aspects relevant to good regulatory practice, with a view to deepening understandi ng of the contribution good regulatory practice can 
make to the implementation of the TBT Agreement.  This Workshop was held to provide delegations 
with an opportunity to  share such experiences.
2 The Workshop was chaired by Mr. R.S. Sidhu (India) 
and moderated by experts from Member government s. The Workshop was organized in four panel 
sessions addressing the following topics:  (i) general approaches; (ii) internal transparency and consultative mechanisms;  (iii) Regulatory Impa ct Assessment (RIAs);  and (iv) regulatory 
cooperation initiatives.  
This report provides a summary of key points and issues that arose in the presentations and 
discussions during the Workshop.  The full presentations made by speakers are available on the WTO 
TBT website .3  A background note by the Secretariat, circulated at the Workshop, is contained in 
document JOB(08)7.   
 
                                                      
1 This document has been prepared under the Secretaria t's own responsibility and is without prejudice to the 
positions of Members and to their rights and obligations under the WTO. 
2 The participation of 102 representatives from deve loping country Members was supported through the  
WTO DDA Global Trust Fund. 
3 WTO TBT Website:  http://www.wto.org/english/ tratop_e/tbt_ e/tbt_e.htm  . G/TBT/W/287 
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Table of Contents 
 
 
 
A. S ESSION 1 – GENERAL APPROACHES ...................................................................................................3 
1. Brazil's new National Gu ide on Good Practice..............................................................................3 
2. Canada's new standards guide for regulators developed by the Standards Council 
of Canada (SCC) ................................................................................................................ ............3 
3. Chile's experience with Good Regulatory Practice ........................................................................5 
4. The European Commission’s Better Regulation Strategy..............................................................6 
5. Japan's Experience and Perspectives on Good Regulatory Practice...............................................7 
6. Korea's Approach to Go od Regulatory Practice.............................................................................8 
7. Malaysia's experience in the preparation for the implementation of Good Regulatory Practice ...9 8. Conclusion .................................................................................................................. .................11 
B. S
ESSION 2 – INTERNAL TRANSPARENCY AND CONSULTATIVE MECHANISMS ..................................11 
1. Colombia's Experience with domestic mech anisms for transparency and consultation...............11 
2. South Africa's Technical Regulatory Framework - A focus on transparency and consultation...12 
3. United States:  The importance of tr ansparency in regulatory reform .........................................13 
4. Conclusion .................................................................................................................. .................15 
C. S ESSION 3 – REGULATORY IMPACT ASSESSMENT (RIA S) ................................................................15 
1. Overview:  Benef its and Appl ication ......................................................................................... ..16 
2. Canada's experience with RIAs............................................................................................... .....18 
3. The experience of Chinese Taipei in promoting Regulatory Impact Assessment........................19 
4. Impact Assessment and Reducing Ad ministrative Burdens in the EU ........................................20 
5. How to Determine If/When to Regulate.......................................................................................2 1 
     6. OECD: Strengthening Trade-Related Policy Coherence in Assessment Tools:  
The Experience of Emerging Economies.....................................................................................22 
7. Conclusion .................................................................................................................. .................24 
D. S ESSION 4 – REGULATORY COOPERATION INITIATIVES ...................................................................24 
1. The US-EC regulatory cooperation initiative...............................................................................25  
2. Israel's Experience in Co operation between Regulators ..............................................................27 
3. India and Regulatory Cooperation ............................................................................................ ...28 
4. Conclusion .................................................................................................................. .................28 
 
  G/TBT/W/287 
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A. SESSION 1 – GENERAL APPROACHES  
1. The moderator, Mr. Jeff Weiss (United States)4, noted that the first session of the Workshop 
was intended to exemplify different  general approaches taken by Me mbers to good regulatory practice 
when implementing the disciplines of the TBT Agreement.  He said  good regulatory practice 
essentially is about the practical implementation of  the TBT Agreement. Effective implementation 
through best practices is an important means of avoiding unnecessary obstacles to trade.  Mr. Weiss 
said many current public policy issues may be releva nt to the implementation of the TBT Agreement, 
including government regulatory policies dealing with climate change, toy safety, chemicals and 
hazardous substances.  
1. Brazil's new National Guide on Good Practice5 
2. Mr. Lobo presented the Brazilian Guide on Good Re gulatory Practices.  He noted that the 
objective of the Guide, among other things, is to contribute to the integration and coherence of 
regulatory practices adopted by Brazilian authoriti es.  Fourteen central government agencies had 
participated in the elaboration of the Guide wh ich was completed in December 2007.  The Guide 
made reference to the work of the ISO/IEC, re levant WTO Agreements (TBT, SPS, TRIPS, GATS), 
the OECD, relevant work in the European Communities and APEC.   The Guide would be 
disseminated through publications , workshops and other capacity building activities directed at 
regulatory agency staff. 
2. Canada's new standards guide for regulato rs developed by the Standards Council of 
Canada (SCC)6 
3. Mr. Shortall presented Canadian policies and met hods on referencing standards in regulations 
and explained the role of the Standards Council of Canada (SCC) in this process.  Mr. Shortall spoke 
about the ways standards are reflected in regula tions, including through direct incorporation into 
statutes;  reference; or reproduction in regulations.  He also introduced RegWatch7, a searchable 
database covering all Canadian, fore ign and international standards re ferenced in Canadian Federal 
Law.  The database provides links to the full text of Canadian regulations that cite standards, as well 
as links to additional information about referenced st andards.  It allows for searches by keyword or 
standard number, developer or regul ation.  It is also possible to find bibliographic information on 
Canadian, US and international standard s referenced in Canadian legislation.8  Mr. Shortall provided 
examples of the data available on selected internati onal, national and foreign standards and illustrated 
one case study (Figure 1) concerning the Canadian Medical Devices Conformity Assessment System 
(CMDCAS).   Attention was also drawn to a recent ISO/IEC publication Use of International 
Standards in Technical Regulations  which assists regulators in making greater use of the standards 
developed by ISO and IEC.9 
                                                      
4 The Annex to G/TBT/GEN/67/Rev.1 contains brief biographies on speakers and moderators. 
5 Presentation by  Mr. Alfredo Carlos Orphão Lobo (Brazil). 
6 Presentation by Mr. David Shortall (Canada). 
7 https://alert.scc.ca/rwh/search_e.jsp.  
8 http://www.scc.ca/ . 
9 http://www.iso.org/iso/standard s_for_technical_regulations.pdf . G/TBT/W/287 
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  Figure 1 
 
 
 
4. In the discussion, several participants asked questions about how to reference standards in 
regulations (Cameroon, China, Hong Kong China, Isr ael, Kenya, Peru).  Mr. Shortall noted that the 
simplest and perhaps most effective way of doing this was by inserting a simple reference to the name 
and date of the relevant standard .  When a change (update) was made to the standard, the regulation 
could be amended.  He noted that in Canada practically all internati onal standards when referenced in 
regulation were adopted in this way. At times,  they could have additional Canadian specific 
requirements embedded taking into account any particul ar legitimate issue that  arose in Canada, for 
instance due to geography or climate.  In general,  it was important that the regulator determined the 
most appropriate means of referencing a particular  requirement (contained in the standard) in the 
regulation. He understood that there may be c oncerns from consumer organizations that the 
regulation, if it only made a reference to the standard, did not contain the full text – but in Canada this 
had not been an issue.   
5. On questions about the cost of using standa rds and intellectual property contained therein 
(Chile, China, India, New Zealand),  Mr. Shortall  said that in Canada all standards had to be 
purchased.  Although standards involved intellectual pr operty and there was a cost, in the Canadian 
experience this had not caused a problem.  Standard izing bodies had agreed with those that provided 
the intellectual property, that this be done on reasonable and non-discriminat ory terms and conditions; 
i.e., at a low cost that benefited all users – wh ether in a developing country or developed country, 
whether a small business or a large business.  Th is system worked well and had enabled the wide 
application of a standard.  There had not been, in the Canadian context, any major concerns raised.  
6. Concerning a question (from the United States)  on the determination of the "relevant" 
international standard, Mr. Shortall noted that Cana da does not have a specific policy on determining 
what constitutes "a relevant intern ational standard".   He noted that the SCC is a member of the 
ISO/IEC system and that Canada generally adopts standards produced by the ISO and IEC as national 
standards.  But Canada also used other standard s which may or may not be deemed international 
standards, including many developed by the US  standards development organization (because they 
meet the needs of Canadian industry and regul ators).  Mr. Shortall said Canada recognizes and  G/TBT/W/287 
 Page 5 
 
 
  follows closely the six principles set out in the TBT Committee's Decision on principles for 
international standards development.10  A key issue of concern in this context is the principle on the 
Development Dimension – the need to ensure that the full participation of developing countries is 
taken into account in the development of those standards. 
7. Concerning the issue of consensus in the standards development process (question from 
Tonga), Mr. Shortall said standards development is by its nature a consensus building process; it is 
about minimizing differences between parties and co ming up with a common solution to a particular 
problem or issue.  Governments could regulate as they wish: governments are given authority to regulate and once they have that authority, they could simply do so without necessarily relying on 
further inputs from stakeholders.  A more "enlightened" governance system would involve 
consultation, not necessarily based on consensus, but that would nevertheless ensure that all views are 
heard and taken into account even if this did not a ffect the final outcome of the regulation. Modern 
governance, as understood by Canada, is to have broa d consultations with affected stakeholders to 
create regulations that are accepted, and that add value. 
8. In response to a question (from Mexico) on wh ether regulators sometimes demand standards, 
Mr. Shortall noted that the Canadian Government  may sometimes request standards development 
organizations to develop standards in support of legal requirements.  In such cases, th e committee that 
develops the Canadian standard is still made up of a broad matrix of interested parties of which the 
regulator  is one.  Mr. Shortall stressed that it was important to ensure broad acceptance of those 
standards so that standards are not written only for re gulators;  standards had to  meet defined goals in 
terms of the interests of manufacturers, producers, consumers and others.  Hence, the process in 
Canada is broad and inclusive even though it co uld be driven by regulatory demand.    
9. On a question (from Mexico), regarding Canadian practice in terms of revision or elimination 
of technical regulations, Mr. Shortall drew the Co mmittee's attention to a new regulatory policy in 
Canada entitled "The Cabinet Dir ective on Streamlining Regulation".
11   
10. A number of participants asked questions a bout conformity assessment (Burkina Faso, Slovak 
Republic). Mr. Shortall said it is difficult for Canadian government regulators to recognize 
laboratories that are not accredited.  He stressed that accreditation is fundamental to foreign market 
access.  Even though the Canadian Government ha d entered into a number of mutual recognition 
agreements involving foreign laboratories a nd foreign conformity assessment bodies, these 
nevertheless needed to be accredited.   
11. On a question (from Zimbabwe) about the market  access effects of private standards – which 
could sometimes be stricter that those set by regulators – Mr. Shortall noted that as private standards 
are not regulated by governments, they do not fall under the full purview of the TBT Committee.  
Nevertheless, these are a "fact of life"; requirements are sometimes set by large organizations (e.g. supermarket chains) in response to consumer pressur es.  Such standards are often more rigorous than 
international standards.   
3. Chile's experience with Good Regulatory Practice
12 
12. Dr. Vallina began by noting that too much or  too little regulation could affect the smooth 
functioning of markets.  Regulation is necessary inter alia  to correct asymmetries of information.  
                                                      
10 Decision of the Committee on Principles for the Deve lopment of International Standards,  Guides and 
Recommendations with Relation to Ar ticles 2, 5 and Annex 3 of the Agreement (G/TBT/9, Annex 4).   
11 This Directive was introduced by the delegation of Canada at the 5 July 2007 Meeting of the TBT Committee 
(G/TBT/M/42, para. 145-146).  More information is also  contained in G/TBT/2/Add. 6/Rev.2 as well as at:  
http://www.regulation.gc.ca/di rective/direct ive01-eng.asp .) 
12 Presentation by Dr. Ana María Vallina (Chile).  G/TBT/W/287 
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  Such regulation ensures the fluid functioning of the market and fair competition.  Dr. Vallina 
highlighted typical legitimate objectives at the root  of government intervention (e.g., protection of 
human health and safety, protection of the environment).  She stressed throughout her presentation the importance of a participatory and inclusive approach to regulation development.   
13. Dr. Vallina described the Chilean Decree on Good Regulatory Practices ( El Decreto de 
Buenas Prácticas Regulatorias ).
13  The Decree stresses principles familiar to the TBT Committee, 
including the obligation to use international stan dards.  It also sets out detailed procedures for 
consultation and promotes the use of accreditation developed by the Chilean National Institute for 
Standardization (INN).14  Dr. Vallina said that in Chile's expe rience certain aspects were essential, 
including: to have a "National TBT Commission" that  participates in intern ational forums (APEC and 
OECD, for instance); to consider experiences of othe r Members; and to maintain dialogue with the 
private sector.  Key challenges include keeping the system up to date, providing support to regulatory 
agencies, improving regulatory impact assessment, and market surveillance. Dr. Vallina noted that, 
for long-term results, it is important that technical work withstand changes in the political sphere (for 
instance because of a change of administration). 
14. In the discussion, questions were posed about  Chile's standards-development process (New 
Zealand, Dominica Republic, Cameroon).  In this regard, Dr. Vallina noted that one of the main 
challenges in Chile is the consultation process at the national level:  there is insufficient time for the 
public to consult regulations in advance, prior to pu blication and entry into fo rce, an issue that the 
Decree addresses.  She noted that the Decree itsel f had been published in its entirety for public 
comment – except parts using standards (for reaso ns of intellectual property rights). Dr. Vallina 
stressed the importance of knowledge of the standa rds-development process.  Chile played an active 
role within regional standardizing processes in the c ontext of the ISO, thereby influencing the drafting 
of standards.   
15. In response to a question about measures take n to ensure that SMEs did not close down 
because of failure to meet regulations (Zimbabwe) , Dr. Vallina said it is important to involve SMEs 
before finalizing regulations bearing upon their businesses.  As well, the Chilean Government 
provides training on impact assessment.  All regulations  in Chile are assessed to ensure they do not 
have unnecessarily damaging effects on SMEs. 
4. The European Commission’s Better Regulation Strategy15 
16. Mr. Santiago dos Santos said the concept of  Better Regulation is essentially about good 
governance and legal certainty.  Ensuring good regu latory practice has a positive impact on conditions 
for growth, employment and productivity:  it pr ovides businesses with the right incentives, cuts 
unnecessary costs, and removes obstacles to adaptab ility and innovation.  Tools to achieve this 
include: impact assessments ( ex ante ); consultation; screening of pending legislative proposals; 
simplification of existing EC legislation ( ex post ); and reduction of administrative burdens ( ex post ).  
The European Communities places emphasis on the impor tance of simplification – a process that aims 
at modernizing and streamlining existing legisl ation, including through: removing unnecessary, 
irrelevant or obsolete legal acts; bringing together all amendments to a given law adopted at different 
times into one law (thereby reducing the volume of EC  legislation); and, revising and clarifying texts, 
                                                      
13 Decreto 77/2004 Ministerio de Economía: Requisitos para la Elaboración, Adopción y Aplicación de 
Reglamentos Técnicos y Procedimientos  de Evaluación de la Conformidad ( LEY 19.912. nov. 2003). 
14 El Instituto Nacional de Normalización (INN)  (for more information, see www.inn.cl.) 
15 Presentation by Mr. Cavan O'Connor Close (European Communities, delivered by Mr. Manuel Santiago dos 
Santos).  G/TBT/W/287 
 Page 7 
 
 
  as well as adapting them to technical progress.  As a result of this work, a total of 300 legal acts had 
been removed from the Community acquis .16  
5. Japan's Experience and Perspectives on Good Regulatory Practice17 
17. Mr. Sugano said good regulatory practice is an  evolving concept and, depending on the forum 
where it is discussed, different elements are emphasized.  He illustrated some of the key elements 
discussed in APEC, including: use of performance -based regulations; referencing of voluntary 
standards; alignment with international standard s; and achieving equivalency through recognition of 
standards from other Members.18  Highlighting Japan's experience with regulatory impact assessment 
(RIAs), Mr Sugano noted that, in October 2007, these were made mandatory for almost all new 
regulations (as well as for changes to, or the abolis hment of, existing ones).  To illustrate, an example 
was provided of how RIAs had been applied to th e revision of Japan's Consumer Product Safety Law 
– a regulation concerning the preventing of acci dents associated with aging consumer products 
(Figure 2).   
18. Mr. Sugano summarized Japan's experiences with  the use of performance-based regulations, 
consultation mechanisms (coordination with stakehol ders) and the use of conformity assessment.  On 
the latter, he stressed that unilaterally allowing fo reign conformity assessment bodies to participate in 
conformity assessment activities is conducive to trade and could be considered as an element of good 
regulatory practice.  Mr. Sugano said that what c onstitutes good regulatory practice differs depending 
on the regulatory environment.  WTO Members need to continue to adopt good regulatory practices, 
and, as GRP was an ongoing process, a step-by-step approach to this is key.  
Figure 2 
 
 
 
                                                      
16 More detail is available at:  http://ec.europa.eu/enterprise/regul ation/better_regulation/index_en.htm . 
17 Presentation by Mr Masafumi Sugano (Japan). 
18 APEC Information Notes on Good Practice for Technical Regulation , September 2000, see also:   
http://www.jisc.go.jp/eng/ap ec-asem/pdf/grp_info.pdf  . G/TBT/W/287 
Page 8  
 
  19. In response to a question on conformity asse ssment in the electrical sector (from United 
States) and, more specifically, the determination by government of the appropriate type of conformity 
assessment procedure to use, Mr. Sugano said a number of factors are relevant in such cases, including regulatory and market environments, as well as  social factors. Ultimately this is a decision 
for the regulator; it is also, to some extent, a politi cal decision.  He said the private sector, on the other 
hand, functions independently: there could be situa tions where, officially, there is requirement for 
third party certification but de facto  the private sector (industry) requires third party certification from 
suppliers.   
20. On a question (from India) about the use of  Mutual Recognition Agreements (MRAs), 
Mr. Sugano noted that Japan currently has MR As with the European Communities, Singapore, 
Malaysia and the Philippines.  The Japanese experience was that official MRAs (treaties) were not as 
productive as had been expected.  This was becau se private sector schemes, such as the IEC CB 
Scheme as well as other mutual recognition arrangements,  were enough to promote market access 
between different countries.  Therefore, in Jap an's view, cross-border designating of foreign 
conformity assessment bodies is more effec tive than negotiating fully fledged MRAs. 
21. In response to questions on RIAs (India, Si ngapore), Mr. Sugano said that the responsibility 
for undertaking an RIA rests on the regulatory agency that is planning to introduce the new (or changed) regulation.  In Japan, the Minister for In ternal Affairs and Communications is in charge of 
liaising with those agencies and overseeing the comp letion of individual RIAs.  Likewise, on the 
assessment of costs and benefits, it is also the re sponsibility of the particular regulating agency to 
collect accurate data, usually from the private sector.   Mr. Sugano said that there is no single way of 
comparing costs and benefits.  For instance, while so metimes it is possible to monetarize costs so as to 
make comparisons, there are other cases that do not lend themselves to monetarization for comparative purposes (such as loss of life), and analysis is therefore done on a qualitative basis.   
22. In response to a question (from Senegal) on ho w the distinction is made between voluntary 
and non-voluntary standards in the standards-deve lopment process, Mr. Sugano said that standards 
and technical regulations in Japan  are developed in two completely  different tracks.  Standards 
development in Japan is a bottom-up process involving inputs, for instance, from the private sector 
and academia. The end result is voluntary and the standards are published as "Japanese Industrial 
Standards" (JIS).  On the other hand, although the development of a technical regulation also includes 
a consultative process, ultimately its nature is di fferent – a regulatory decision taken by government 
derives its authority from elected politicians.  In some cases, technical regulations could cite a 
particular standard (see Mr. S hortall's, paragraph 3 above). 
6. Korea's Approach to Good Regulatory Practice
19 
23. Dr. Rhyu noted that principles of GRP (efficiency, effectiveness, clarity, non-discrimination 
and openness) are legislated in three laws whic h constitute the legal basis for GRP in Korea.20  A  
"Regulatory Reform Committee" (RRC), established in 1998, set the basic direction of regulatory 
policy, including: undertaking public consultatio n; reviewing newly established regulation; and 
regular monitoring and evaluation of regulatory impr ovement.  As a result, the number of regulations 
in Korea had decreased over 10 years from 11,125 (in 1997) to 5,116 (in 2007).  Dr. Rhyu explained how technical regulations are developed in Korea (F igure 3).  She noted that 13,957 Korean industrial 
standards had been harmonized with relevant inte rnational standards and that, currently, only a small 
proportion of Korean standards are different from th e international standards.  Dr. Rhyu introduced 
Korea's Electric Appliances Safety Control Act.  Sh e explained the differentia l approach to Supplier's 
                                                     
 
19 Presentation by Dr. Gyung Ihm Rhyu (Korea). 
20 Administrative Procedures Act (1996), Basic Act on Admi nistrative Regulations ( 1998) and National Standards 
Act (1999).  G/TBT/W/287 
 Page 9 
 
 
  Declaration of Conformity (SDoC) as applied in Kor ea.  For instance, while full SDoC is used in the 
automobile sector (where the mark et surveillance system is well estab lished), in the low-risk electrical 
appliance sector, a modified SDoC would be applicable from 2009.21  
Figure 3 
KATSKATS
 Development Procedures of TR
Drafting Proposal (RIA)
Inter-Ministerial Consultation
Examine any overlap or inconsistency with the existing regulations,
and consistency with the WTO/TBT agreements
Consultation with Interested Parties
Public notification with a comment period of at least 20 days
* At least 60 days for regulations related to Economy and Trade
Regulation Review
The Regulation Reform Committee (RRC) reviews the regulatory 
objective and anticipated results clarity of regulation results of 
consultation with stakeholders anticipated problems
 
 
 24. In the discussion, a question was raised with r espect to the use of SDoC (United States).  
Dr. Rhyu stressed the importance of efficient and e ffective post market surve illance systems. She said 
that this was the key factor in deciding whether or  not to use SDoC.  She noted that some countries 
could have a well established private certification system where the consumer was familiar with the 
certification mark.  Such private certification systems, by providing a supporting mechanism for conformity assurance, could help government in troduce full SDoC, for instance, in the electrical 
safety sector.  In respect of a question on RIAs (S ingapore), Dr. Rhyu noted that in Korea regulatory 
impact assessments were either undertaken by  the regulator itself or the private sector. 
7. Malaysia's experience in the preparation fo r the implementation of Good Regulatory 
Practice
22 
25. Mr. Raj noted that technical regulations in Malaysia are normally de veloped as subsidiary 
legislation under laws approved by the elected members of Malaysia's National Parliament. The 
process had developed over time and was not based on laws or codes – rather, it had been built up 
through a series of administrative decisions.  Mr. Raj noted that, currently, although stakeholder consultation (an important element of good regulatory practice) is part of the process, there is no 
defined way of undertaking such c onsultation and it is not mandated by  law.  The key objective for 
Malaysia in the area of good regulatory practice is  to improve the quality of new regulations and 
upgrade the quality of existing ones.  In fact, ther e had been early recognition by economic planners 
in Malaysia of the impact of inappropriate  regulation as a barrier to investment and productivity 
                                                     
 
21 For more information on the implementation of the TBT Agreement in Korea see: 
http://www.kats.go.kr /english/index.asp . 
22 Presentation by Mr. Rajinder Raj (Malaysia). G/TBT/W/287 
Page 10  
 
  improvements.  Mr. Raj provided an extract from an economic planning policy document dating back 
to 1991:  
“The process of deregulation will continue. There can be no doubt 
that regulations are an essential part of the governance of society, of which the economy is a part. What is not required is over regulation 
although it may not be easy to decide when the Government is over 
regulating.  
Wisdom lies of course in the ab ility to distinguish between those 
laws and regulations which are productive of our societal objectives and those that are not; and it lies in making the right judgements with 
regard to the trade-offs. In this li ght and given the fact that there are 
clear areas of unproductive regulation which need to be phased out, you can expect the process of produc tive deregulation to continue.”   
Extract from Vision 2020 - Economic Planning Unit (1991) 
26. The minimum process to develop regulations in Malaysia follows the steps outlined in Figure 
4, below.  Mr. Raj noted that among other recent initiatives, Malaysia had est ablished a national level 
Central Coordinating Committee with the role of  managing the implementation and review of 
technical regulations.  The Committee would cont ribute to addressing some of the key challenges, 
including: raising awareness and understanding of the importance of good regulatory practice at the 
policy and decision making levels; knowledge and skills of regulatory agencies and legal institutions; 
and, overcoming fear of the unknown as well as entren ched institutional practices. Mr. Raj noted that, 
at the end of the day, final decisions are made by  political leaders and political will needs to be built 
up.  
Figure 4 
24/04/2008WTO TBT Committee 
Workshop on Good Regulatory Practice9Minimum  Process Steps
Implementation  date fixed Publication  in Gazette 7All drafts vetted by legal experts, 
Minister’s  authorityFinalization/approval  by 
AG’s Chambers  & Minister6Drafting by ministry officials, 
consultation.Development  of regulation 5To obtain views of affected 
ministries/agenciesInter‐Ministry consultation 4Usual practice to obtain overall 
agreementCabinet Paper 3Minister has final authority  under 
Malaysian  lawMinistry agreement  to 
proceed 2Developed  by Ministry/Agency  
ResponsibleProposal 1
 
 
27. In response to a question about how standards are referenced in Malaysia (Mauritania), 
Mr. Raj said some regulators incorporate voluntary st andards in technical regulations by reference 
(similar to the method described by Ca nada, above).  In most cases this  is done by direct reference to  G/TBT/W/287 
 Page 11 
 
 
  the standard itself without reproducing the text. In  other words, the reference "incorporates" the 
standard into the technical regulation and the whole standard becomes part of the technical regulation. 
8. Conclusion 
28. In concluding the discussion, the moderator recalled that the TBT Agreement is about 
avoiding unnecessary barriers to trade and good regulato ry practice is about its implementation.  In 
this regard, the presentations and discussion had s hown there are many ways of implementing the 
Agreement and Members are at different stages of this process.  A key challenge for many Members is to find ways to keep regulations up-to-date and re levant and to ensure that agencies dealing with 
regulation have appropriate res ources.  Another key message from the session was the importance 
given to established processes and procedures as a m eans of giving effect to good regulatory practice.  
Although there are many different ways of implem enting the TBT Agreement, having a basic process 
(as illustrated by several of the speak ers) backed by some form of le gal instrument strengthens efforts 
to integrate good regulatory practice into Members' re gulatory structures.   Mr. Weiss noted that many 
current trade issues are about regulation (climate ch ange, toys, healthy food), so the importance of the 
TBT area appeared to be growing.   
B. S
ESSION 2 – INTERNAL TRANSPARENCY AND CONSULTATIVE MECHANISMS  
29. The moderator, Mr. Peter Bischoff-Everding (European Communities)23, recalled that at the 
Special Meeting on Procedures for Information Ex change (held in November 2007), the Committee 
had discussed transparency issues in depth.  The meeting had shown that transparency is very much a 
fundamental pillar to good regulatory practice.  In  particular, Members had attributed importance to 
openness, transparency and accountabil ity in regulatory processes.   
1. Colombia's Experience with domestic mech anisms for transparency and consultation24 
30.  Mr. Madriñan said that the regulatory process in Colombia starts with a public notice at an 
early stage in the Colombian Offici al Gazette (Figure 5).  This no tice includes information about the 
products to be regulated, the regulating entity and the legitimate objective of the regulation.  A similar 
(simplified) process exists for reviews of techni cal regulations, which are done approximately every 
five years. 
Figure 5 
 
 
                                                      
23 The Annex to G/TBT/GEN/67/Rev.1 contains brief biographies on speakers and moderators. 
24 Presentation by  Mr. Ramón Madriñan (Colombia).  G/TBT/W/287 
Page 12  
 
  
 
 
31. Mr. Madriñan said the benefits of the regulator y process are several:  it gives legitimacy to 
government action and helps the gove rnment organize its work; it raises awareness among interested 
stakeholders (including with respect to internatio nal agreements that Colombia is a party to); it 
improves the text of technical regulations; and help s avoid unnecessary barriers to trade.  In addition, 
consultations help the government discern needs fo r assistance within the coun try, for instance with 
respect to SMEs.  Mr. Madriñan described some of  the challenges as well, including: the time and 
effort needed to ensure all aff ected parties are aware of and attend public hearings; problems arising 
from the fact that not all interested groups stand on equal footing; and the fact that consultations are 
used sometimes by groups to try to restrict competition.  Looking ahead, Mr. Madriñan said Colombia intends to share experiences with other Andean  Community regulators and develop a guide on good 
regulatory practice that promotes regional integration.
25  
32. A number of questions were posed about the c onsultative process in Colombia (Switzerland, 
Zimbabwe and Turkey).  In respect of coordination before  the issuance of the first draft, 
Mr. Madriñan noted that there exists in Colombia  a consultative process among regulators prior to the 
publication of the first draft.  Regarding how to maximize participation in  the consultation process 
(and particularly how to reach the "uninterested "), Mr. Madriñan said Colombia sometimes used 
campaigns to inform the public (posters or flyers).  He noted that a less costly approach is to send out 
letters to parties previously identified as interested.  Mr. Madriñan said it is important that participants 
express their opinions during  the process, not after. 
2. South Africa's Technical Regulatory Fr amework - A focus on transparency and 
consultation26 
33. Mr. Brits said the purpose of South Africa's  National Technical Regulatory Framework 
(NTRF) is to establish a common South African appr oach to technical regulatory responsibilities.  The 
strategy is intended to provide guidance to al l departments responsible  for the development, 
maintenance and review of technical regulations.  Its core principles include: transparency; use of 
least trade restrictive measures;  internationall y harmonised measures; necessity; proportionality; non-
discrimination; and special and differential treatme nt. Regarding transparency, the NTRF establishes 
mechanisms for: consultation and participation; ex change of information; and co-ordination amongst 
various institutions that are part of the technical regulatory infrastructure.  Mr. Brits said transparency 
is important as it enhances predictab ility and clarity, thus providing tr aders with certainty. In general, 
the South African approach to transparency is intended to promote innovation and competition 
amongst businesses and thereby ensure benefits to c onsumers and society.  Mr. Brits said there had 
been clear gains from this strategy, including an increasingly open and predictable economic system 
where environmental and social interests are suppor ted without excessive technical regulations being 
imposed on business. 
34. In response to a question (from the European  Communities) on the development process of 
technical regulations, Mr. Brits said the process d escribed above is about the initial stages of the 
                                                      
25 The Guide is available, in Sp anish, at www.mincomercio.gov.co. 
26 Presentation by  Mr. Rudolf Brits (S outh Africa) with interventions by Mr s. Rene Heydenrych (South Africa).   G/TBT/W/287 
 Page 13 
 
 
  development of a technical regulation, before  it is to be published as a draft regulation in the South 
African Government Gazette which, in turn, a llows for the general public to comment on it. 
35. In response to a number of questions (including from Burkina Faso and St Lucia) on the 
nature of South African's "compulsory standard s", Mr. Brits explained that South Africa had 
previously had problems with various department s issuing mandatory regulations or "compulsory 
standards" in different formats.  The intenti on of the above-mentioned Fr amework is to ensure 
through the development of good regulatory prac tices that all government departments develop 
technical regulations – where necessary – in the same way, using the same consultative process, 
including comments from the general public. 
36. One participant (Hong Kong, China) asked about practical examples of the implementation of 
the principles enumerated by Mr. Brits in his presen tation.  In response, it was explained that with 
respect to "necessity", South Africa had had a proble m with the enforcement of technical regulations 
that had an unnecessarily severe impact on small businesses (SMEs) within the country;  it had 
happened that SMEs that could not comply with the government's own regulations simply gave up 
production.  Mr. Brits stressed that this emphasized the importance South Africa attaches to ensuring 
the necessity of regulation.  
3. United States:  The importance of transparency in regulatory reform27 
37. Mr. Jeff Weiss said transparency is important for several reasons.  A transparent process 
makes regulators accountable for their decisions and this provides incentives to ensure the analysis 
behind the regulation is sound.  Due process leads to greater public understanding of the purposes and 
effects of regulation, as well as increased public co nfidence in the fairness and predictability of the 
system.  In turn, better regulations achieve regul atory objectives while maximizing net benefits and 
are less likely to create unnecessary barriers to trade – leading to higher levels of economic growth. 
Figure 6 
 
                                                      
27 Presentation by Mr. Jeff Weiss (United States) with interventions by Mr. Neil Eisner (United States). G/TBT/W/287 
Page 14  
 
   
  38. In describing the US approach to regulatory policy, Mr. Weiss explained that in the United 
States there exists a separation of powers betwee n three branches of the US Government at the 
Federal level: the legislative, the executive and the judicial (three columns in Figure 6).  The Office of 
Management and Budget (OMB), an agency located  in the Executive Office of the US President, 
provides centralized management and leadership of  the federal regulatory process; it ensures that 
regulators ask the same questions and follow the same procedures.   
39. An important part of the regulatory process pr ovided for in the Administrative Procedures Act 
(enacted in 1946) is the "Notice and Comment" syst em.  This system requires that agencies undergo a 
process open to all interested parties, both foreign and domestic.  The basic elements of the Notice 
and Comments system are: (i) the publication of propo sed regulation (in the U.S. Official Journal, the 
Federal Register – in this context Mr. Weiss said that notification is made to the WTO of proposed 
technical regulations soon after these are published in  the Federal Register, whether they were based 
on relevant international standards or not); (ii) the comment period (there is no restriction on who 
could submit comments and equal treatment is offe red to all comments received);  and (iii) the 
publication of final regulation (it was noted that comm ents received need to be addressed in the final 
regulation). 
40. Mr. Weiss noted that a significant development w ith respect to transparency resulted from the 
Executive Order on Regulatory Planning and Review (Executive Order 12866), issued by President 
Clinton.  This Order had focused OMB's overs ight on significant regula tions and increased the 
disclosure procedures for contacts with outside parti es.  Pursuant to this Executive Order, federal 
agencies need to submit drafts of significant regula tions (both proposed and final) to the OMB for a 
90-day review before publishing them in the Federa l Register (see boxes containing "OMB" in Figure 
6).  "Significant" regulations are those regulations  that, for example, raise novel policy issues, are 
inconsistent with an action take n or planned by another agency, or economically significant (more 
than USD100 million a year in economic effects).  It  was also pointed out that the OMB had to issue a 
report to Congress each year estimating the costs and benefits of regulations in the aggregate, by 
agency and agency programme, and by regulation. 
41. Mr. Weiss noted that when regulations are unde r OMB review, the USTR had opportunity to 
review and comment on international trade impl ications.  Comments received in response to 
notifications, whether received from the enquiry  point, raised at TBT Committee meetings or 
discussed on the margins of such meetings, were transmitted to regulators.  Thus, the TBT process 
helped inform US positions. 
42. In response to a question (from Bahrain) on admi nistrative procedures in respect of changes 
made to a draft regulation, Mr. Eisner (United States ) clarified that if the changes could reasonably be 
anticipated by the public, the agency did not n ecessarily have to provide a second comment period – 
although they sometimes would on a voluntary basis.  If, however, the changes were outside the scope 
of the notice (something the public could not have expected) the agency was required to do a supplementary notice and provide another opportunity for comment. 
43. In response to a question (from Brazil) about  cases (5 per cent) where notice and comments 
procedure is not used, Mr. Weiss (United States) said there could be urgent situations where a 
regulator could proceed directly to the final st age and there were cases where the United States 
Congress could direct an agency to proceed straight to the final stage.  Mr. Eisner (United States) 
noted, in addition, that are a whole category of regulations where agencies could make a 
determination that public comment is not necessary. The Federal Aviation Administration could 
amend an approach path to airports for instrument  approach procedures, because, for example, a tree  G/TBT/W/287 
 Page 15 
 
 
  on the approach path had grown taller. In such cases of rule making it is not considered necessary to 
seek comment. Nevertheless, these decisions would remain subject to judicial review, keeping the agency in question accountable. 
44. In respect of questions (from India and Ch inese Taipei) about "significant impact" 
(regulations resulting in more than USD100 million a year in economic effects), Mr. Weiss said about 
2,000 regulations were adopted every year and of these the OMB reviewed 500 to 700.  In turn, about 
70 to 100 of these regulations were economically significant.  The OMB also reviewed those 
regulations that dealt with novel policy questions as well as draft regulations that required interagency 
coordination (even if not economically significant) .  Mr. Weiss noted that the USTR is involved 
throughout the process so as to monitor possible e ffects and impact on other WTO Members seeking 
thereby to pre-empt any issues that could ot herwise be raised in the TBT Committee. 
45. In response to a question posed (by Peru) to several speakers on the powers of local 
governments to implement technical regulations, Mr. Madriñan (Colombia) said, in theory, certain 
local authorities are empowered to expedite technica l regulations. However, in practice, this power by 
local governments is not exercised in Colombia.  Mr. Brits noted that in South Africa’s case, the local 
government is allowed to implement technical regul ations but this was mostly with respect to 
regulations related to building sta ndards and environmental matters. Hence, with respect to goods that 
are traded internationally, they are not able to regulat e.  He said that the area of internationally traded 
goods is the responsibility of the South African Bu reau of Standards (SABS) or certain other 
government departments.  Mr. Weiss (United States) noted that proposed regulations at the US State 
level also are notified to the TBT Committee. 
4. Conclusion 
46. In concluding the session, the moderator observed that transparency, openness and 
accountability are relevant to many, if not all, aspects of good regulatory practice.  The Session had focused particularly on mechanisms to enhance tr ansparency in the development stage of proposed 
regulations (before a notification was made to the WT O).  It had been stressed that participation by 
stakeholders helps ensure legitimacy of the meas ures governments choose to implement.  Consultative 
processes enhance predictability and cl arity, providing certainty for trad ers, and helps also to increase 
awareness about government actions.  The importan ce of coordination between the standards bodies 
and relevant government de partments that established technical re gulations had also been emphasized. 
In terms of challenges, the moderator recalled th e importance of ensuring that consultative processes 
are not dominated by particular interest  groups.  As well, consultation should not be considered by 
regulators as a burden but rather as an instrument that  adds legitimacy to regulatory decision-making.  
Finally, insufficient resources to improve technical  and regulatory capacity remained a constraint in 
many countries.   
C. S
ESSION 3 – REGULATORY IMPACT ASSESSMENT (RIA S) 
47. The moderator, Mr. Rajinder Raj (Malaysia)28, noted that at the Fourth Triennial Review of 
the TBT Committee, Regulatory Impa ct Assessments (RIAs) had been identified as one tool to assist 
regulatory decision-making.  The current session was intended, inter alia , to address how RIAs can 
assist regulatory decision-making, including with resp ect to factors used by regulators to determine 
whether there is a need to regulate in a given situ ation or whether other instruments are better suited 
to fulfil the legitimate objective sought.   
                                                      
28 The Annex to G/TBT/GEN/67/Rev.1 contains brief biographies on speakers and moderators. G/TBT/W/287 
Page 16  
 
  1. Overview:  Benefits and Application
29 
48. Mr. Jacobs said national standards are products of a complex national system of regulation 
composed of a mix of institutions, people, pro cedures, incentives and relationships.  Regulatory 
reform is about changing the way the system  operates as a whole so as to make possible sustainable 
improvement in the quality of regulations that are produced and implemented. "Regulation" is a wide 
ranging concept which encompasses:  laws (inclu ding by-laws at the lowest government level), 
ministerial decrees, and legal instruments used to impose requirements on non-government actors.  
Mr. Jacobs said regulation is a legiti mate part of government activity that has, over the last 20 years, 
become a major policy tool of government.  The mo st productive economies in the world – as well as 
the most advanced – regulate extensively. The challenge today is not deregulation but, rather, smart  
regulation.   
49. In Mr. Jacob's view, most governments have lost control of their regulatory systems. Today, 
these are often so fragmented, decentralized, and captu red by special interests that national regulatory 
practices are extremely resistant to reform.  This  has made the task of managing regulatory systems 
difficult for national governments. Yet change is needed. Good regulation is about changing the 
competitive incentives facing businesses, either by cha nging the cost structures or the risks faced. 
Unless regulatory reform changes the behaviour of  business on the ground, it will not succeed because 
it is the micro-economy (the day to day decisions  of businesses) that drives growth.  By reducing 
costs and changing the risk premium included in the co st of capital, it is possible for regulatory reform 
to make attractive a broader range of projects th at is not attractive under a high risk / high cost 
regulatory system.  Regulatory systems with lower co st and lower risks are more efficient at solving 
problems, have higher rates of compliance and produce,  in general, more bene fits in protecting public 
interests. 
50. Mr. Jacobs illustrated four main regulatory reform  tasks in a so-called "pool analogy" (Figure 
7, below).  The first task is to clean the water in  the pool:  countries have built up enormous stocks of 
rules and laws and procedures that are decades – ev en centuries – old.  This "regulatory museum" 
represents past problems and past solutions that of ten do not match the future needs of the country. 
Second, the water flow (into the pool) is important: if new regulations do not meet quality standards, 
then the pool will quickly become dirty again with  outdated regulatory designs and principles . Hence, 
it is important to have strong filte rs and quality controls on the infl ow of new laws and regulations. 
Because Regulatory Impact Analysis (RIA) is in  essence a quality control mechanism on new ideas, 
RIA plays an important role in this context.  Third, there is a need to ensure that the pool 
infrastructure is sound:  in other words, all the institutions and processes that are necessary to produce 
and implement regulations (inspectorates, ministries , parliament, cabinet, the judiciary, the national 
gazette, etc.) must be in place and functioning well.   Fourth, there must be somebody responsible for 
the pool, a person who tests the water quality to ensu re that it is clean enough and remains that way. 
This is a problem in most countries; because of the fragmented nature of the regulatory system, 
nobody is in charge with a global view of the whol e system. Altogether, these four tasks form the key 
components needed in a modern regulatory syst em within which RIA has an important part:  
regulatory quality control. 
                                                      
29 Presentation by Mr. Scott Jacobs (Jacobs and Associates).   G/TBT/W/287 
 Page 17 
 
 
  Figure 7:  Four Main regulatory Reform Tasks 
 
 
51. Mr. Jacobs said around forty countries have adopted  formal requirements for RIA, and, in his 
estimation, RIA affects laws and regulations govern ing about 70 per cent of world GDP.   Currently, 
RIA is part of the mainstream of  economic governance and there is signi ficant investment in it, and an 
increase in their use (Figure 8).  For instance, ove r 20,000 RIAs have been done in the United States 
since 1981, and, in the European Communities, al most 200 RIAs will be done in 2008, increasing 
sharply since the launch of the current RIA program in 2003.  
Figure 8 
 
 
52. Mr. Jacobs said that an RIA is not a technical methodology but rather a process of ordering 
the right questions in a structured format to suppor t a wider and more transparent policy debate. It is 
about systematically and consistently examini ng selected potential impacts arising from government 
action or inaction. And it is about communicati ng this information to decision-makers and 
stakeholders. Communication  is central. The results of RIA are becoming clearer. RIA induces governments to "think harder" about how they will so lve problems and is therefore associated with an 
increase in the use of alternatives to regulation. Mr. Jacobs stressed that even in countries that have 
little experience with analytical methods, RIA can be  undertaken effectively and need not be complex G/TBT/W/287 
Page 18  
 
  or costly.  In fact, significant intermediate results  could be seen even when the quality of RIA is low 
in the first years of adoption. Mr. Jacobs said the process of undertaking an RIA – by asking new questions and engendering a more vigorous public debate – is more important in improving the 
quality of public policies than the empirical precision of the analysis. 
53. In response to a question (from the modera tor) about how countries have overcome the 
political hurdle to achieve change, Mr. Jacob said resi stance to change is common and he stressed the 
need to achieve a climate  of change – if the preconception is that “everything is fine”, change will not 
happen.  Sometimes change is brought about by a cl imate of crisis. A more frequent driver, however, 
is trade agreements, whether regional or global.  For example, NAFTA drove regulatory reform in 
Mexico.  A key reason for regulatory reform in Viet Nam and China was accession to the WTO.  
Also, joining the Europ ean Communities was (and currently is) an important driver of regulatory 
reform.  Such agreements open the political debate  and increase the power of reformers in national 
governments.  Also, at times, competitiveness con cerns have alerted governments to the need for 
better regulation.  In terms of actually implementing change, there should be a coalition of ministers 
or decision-makers ready to lead; one single person (a  "champion" of change) is not usually enough.  
54. Regarding the costs of doing an RIA (question from Morocco), Mr Jacobs noted that with 
respect to relative costs, studies in the Unite d States and the European Communities show a 
government investment of US$1 or €1 produces approximately 10,000 USD or Euros in cost savings to the economy. Even considering only government cost s, Mr. Jacobs was of the view that if the RIA 
is well planned and implemented properly, it did not result in net budget increases; it was either 
neutral or budget reducing. 
2. Canada's experience with RIAs
30 
55. Ms Zarrouki observed that Canada had over 20 year s of experience with RIAs.  Nevertheless 
improving on RIAs is a continuous process – they ar e, in essence, the public face of regulation.  They 
are used to identify the reason for regulating, how Canadians have been consulted, what the impacts 
of proposed regulations are, and how the regulati on would be enforced.  An RIA is a communication 
tool as well as a decision-making tool.  In Canada, dr aft regulations are published together with the 
RIAs in the Canada Gazette  to give Canadians and other in terested parties (including other 
governments and international companies) opportunity to provide input.   
56. Ms Zarrouki informed participants that, as of 1 April 2008, a new RIA format would be 
implemented in the context of the new Canadian re gulatory policy set out in the Cabinet Directive on 
Streamlining Regulation (CDSR).31  She said the overall intention of the new format, which has been 
developed using a consultative appr oach, is to provide the public a nd decision-makers with increased 
transparency, analysis and accountability.  Th e new RIAs would demonstrate and explain inter alia  
the choice of instrument (e.g., re gulation, voluntar y practice) and the potential impact on business and 
trade. There would be more focused analysis incl uding in "high" impact regulations and a description 
of links to broad government policy objectives.     
57. A key benefit of RIAs is consistency in appro ach for all federal regulators.  Other benefits 
include: increased communication, enhanced accountab ility, transparency in decision-making, and, 
shedding light on alternative approaches.  In terms of challenges, especially following the introduction 
of CDSR, Ms Zarrouki noted that there is a growi ng need for robust data.  Also, regulators will need 
to furnish increased effort to include new elements in RIAs and acquire new skills to do so; capacity 
building is essential.  In this regard, Canada has formed a Centre of Regulatory Expertise to give 
specialized advice and has developed training courses and several guides.   
                                                      
30 Presentation by Ms Karen M. Zarrouki (Canada). 
31 The Cabinet Directive on Streamlining Regulation is available at http://www.regulation.gc.ca/  .  G/TBT/W/287 
 Page 19 
 
 
  58. In response to a question about who implements RIAs and the scope of their application (from 
European Communities and Chile), Ms Zarrouki said most RIAs are done internally by government.  
Nevertheless, sometimes when know-how and capacity are a constraint, certain aspects of the analysis 
could be contracted out to third parties.  On sc ope, Ms Zarrouki said RIAs apply to many different 
kinds of regulations, including with respect to h ealth and safety, food processing, the banking sector, 
the automotive industry, etc.  In other words – the application of RIAs is ge neral, and not limited to 
regulations falling under the sc ope of the TBT Agreement. 
59. In response to a question about the assess ment of performance (from Burkina Faso), 
Ms Zarrouki noted that key to performance assessment is the choice of the right indicators.  In this 
regard, it is particularly important to be clear about the objective of the regulation. 
60. In response to questions on the nature of the Centre of Regulatory Expertise, its role and 
assistance provided to other countries (European Comm unities, New Zealand, Morocco and Senegal),  
Ms Zarrouki clarified that the Centre is a govern ment body within the Canadian Regulatory Affairs 
Sector.  Its main role is to help develop RIAs fo r the Canadian government.  Ms Zarrouki took note of 
the need for assistance expressed by some pa rticipants for the development of RIAs. 
3. The experience of Chinese Taipei in pr omoting Regulatory Impact Assessment32 
61. Ms Huang noted that the current administrati on had initiated several policy measures aimed at 
promoting RIAs since the year 2000. In particular, a special group was established to undertake organisational reform, targeting f our core concepts in particular : deregulation, decentralization, 
corporatization and outsourcing. She explained that a "Golden Axe" award was established to 
encourage civil servants actively to take initiativ e for change.  This competition included four 
categories: administration reengineering, deregulat ion and innovation, attracting investments, and 
cross-agencies cooperation.  Another important land mark in Chinese Taipei w as the establishment in 
2006 of several tools for the promotion of good regulatory practice. One of these tools is an operational flow chart for a general law proposal (Fi gure 9).  Under this law, all agencies are advised 
to follow the steps set out in th e flowchart as well as to compile a preliminary RIA report.  For 
significant law proposals, agencies are also requi red to conduct an advanced RIA (with a separate 
operational flowchart). 
                                                     
 
32 Presentation by Ms Jennifer Fa ng-Yu Huang (Chinese Taipei).  G/TBT/W/287 
Page 20  
 
  Figure 9 
 
 
 62. Ms Huang drew participants ’ attention to the APEC-OECD Integrated Checklist on 
Regulatory Reform
33, noting that this document is a comprehensive policy tool that had been useful to 
Chinese Taipei. Ms Huang emphasized the importance of capacity building in the area of regulation 
and RIAs. 
4. Impact Assessment and Reducing Administrative Burdens in the EU34 
63. Mr. Santiago dos Santos described the EC stra tegy to reduce administrative costs by 25 per 
cent by 2012.  Under this strategy, which is linke d to the simplification effort (see paragraph 16, 
above), EC member States are called upon to de velop their own programmes and targets on 
legislation falling under their own na tional targets. He stressed that the purpose of this exercise is not 
deregulation – it is about reducing costs stemmi ng from EC legislation, particularly on SMEs. 
Administrative costs are those incurred by private businesses in meeting legal obligations to provide 
information on their action or production, either to p ublic authorities or to private parties. The term 
“information” in this context is to be construed in a broad sense, i.e. including costs of labelling, 
reporting, monitoring, permitting and assessment needed to provide the information and registration.  
A number of priority areas for this exercise were identified.35   
64. In respect of impact assess ments in the European Commun ities, Mr. Santiago dos Santos 
noted that, since 2003, when im pact assessment became mandato ry for all European Comission 
proposals, more than 300 impact assessments had b een completed.  Guidelines for impact assessments 
were updated in 2005 and 2007, and, in that rega rd, greater emphasis was put on competitiveness 
issues and administrative burdens.  Mr. Santiago dos Santos emphasized that impact assessments are 
                                                      
33 Available at http://www.oecd.org/dataoecd/41/9/34989455.pdf . 
34 Presentation by Mr. Cavan O'Connor Close (European  Communities), delivered by Mr. Manuel Santiago dos 
Santos.  
35 More information is available at http://ec.europa.eu/enterprise/a dmin-burdens-reduction/home_en.htm .  G/TBT/W/287 
 Page 21 
 
 
  an aid to political decision-making, not a substitute for it. In response to a question (from Antigua and 
Barbuda), it was noted that all the European Communi ty's work on impact assessment is available for 
the public on the EC Europa Impact Assessment Board  website, including the impact assessments and 
short summaries of them in different languages.36  
5. How to Determine If/When to Regulate37 
65. Mr. Eisner began by emphasizing to participants  that before any executive branch agency in 
the United States could issue a regulation, the US Co ngress had to delegate to that agency either the 
authority or the responsibility for issuing those re gulations.  The delegati on could range from broad 
discretion (e.g., set minimum levels of safety for automobiles) to a specific mandate (e.g., require 
airbags in all automobiles).  Sometimes, RIAs coul d be used to ask Congress to change the statutory 
mandate when the specific action that was mandate d was problematic (see example in paragraph 71, 
below). 
66. Mr. Eisner pointed out that a number of different factors affect an agency's decision-making.  
The need  for a regulation could be sparked, for instance, by a report from an inspector, accident 
reports, changes in the state of the art, or revi ew of existing regulations.  Also the public could 
petition for change, or such requests could come  through policy initiatives (for instance when there 
was a change of administration).  Investigative agencies could also produce recommendations that might initiate regulatory action.  
67. In considering how to regulate, it is important to keep  in mind the non-regulatory alternatives, 
i.e., posing the question:  is there really a n eed to mandate specific action?  Non-regulatory 
alternatives could include: market place incentives, voluntary partnerships, or tax incentives.  For 
instance, with respect to fuel economy in automobil es, raising the tax on fuel could be more effective 
than requiring specific average fuel economy standa rds.  Mr. Eisner said it is also important to 
continuously reconsider the need for regulation in the first place as the different alternatives are 
assessed.  Also, different regulatory alternatives (differe nt ways of regulating) need to be considered; 
for instance, information disclosure (through labelli ng, for instance) could be required rather than 
requiring a particular testing procedure.  Other factors also need to be taken into account when 
regulating, such as: use of international standards,  use of performance standards where possible, and  
acceptance of alternative methods for compliance. 
68. Concerning risk assessments and cost-benef it analyses, Mr. Eisner emphasized the 
importance of underlying assumptions and the usefulness of sensitivity analyses.
38  He stressed that 
cost benefit analysis needs to be done before  the decision is made, and not in support of it.  In the 
process of considering these factors, public comment  is essential – there ha ve been several cases 
where regulatory proposals had been withdrawn becau se they were found not to be cost beneficial.  
Also, the US Congress and US courts could overturn or remand proposed regulations.   
69. Mr. Eisner emphasized the following questions on the "logic of the decision" to regulate:  
• Is problem/policy goal clear? 
• Will the action fix the problem? 
• Are conflicts with other objectives and requirements explained and justified? 
• Will the action promote or hinder innovation,  competition, trade, and investment? 
                                                      
36 More information is available at http://ec.europa.eu/governance/b etter_regulation/impact_en.htm . 
37 Presentation by Mr. Neil Eisner (United States).  In add ition to this presentation, more detail is available in a 
document submitted by the United States:  Determini ng the Need to Regulate (G/TBT/W/285, 19 March 2008). 
38 For more detail on risk assessment and cost benefit analysis, see Sections E a nd F of document G/TBT/W/285.  G/TBT/W/287 
Page 22  
 
  • Do data/analyses support decision? Are costs and market distortions minimized? 
Benefits maximized? 
• Is the action sensible?  
• Are assumptions reasonably explained and supported? 
• Are there reasonable alternatives and explanations for rejection? 
• Could action have unint ended consequences? 
• Is it clear, practical, and easily enforced? 
• If problem continues, will agency be able to explain why its decision was reasonable? 
70. Mr. Eisner concluded by stressing the importance of economic analyses in RIAs.  A well done 
analysis is an exceptionally valuable decision-making tool.  If the process is used correctly, regulations are much less likely to create trade barriers or other problems. 
71. In response to a question (from the European  Communities) about the implementation of 
specific mandates from the US Congress, Mr. Eisner gave an example of how a RIA and public comment could lead to a statutory mandate bei ng withdrawn.  In the 1980s, the US Congress 
mandated that the executive branch require mud fl aps ("splash and spray suppression devices") on all 
commercial motor vehicles operating in the United St ates.  Because there were so many commercial 
motor vehicles on which these devices would have ha d to be installed, and because they would only 
last about two years, it had been estimated that the cost would total ¾ of billion US$ every year.  After some specific tests it had been shown that th e amount of reduction in splash and spray through 
the use of mud flaps would not be discernible by th e human eye (in other words, the mud flaps were 
not effective).  After presenting this information to the US Congress, the statutory requirement was 
withdrawn. 
6. OECD: Strengthening Trade-Related Policy Coherence in Assessment Tools:  The 
Experience of Emerging Economies
39 
72. Mrs. Fliess described the different phases of re gulatory reform (Figure 10).  She noted that 
OECD countries, having developed and explored th e use of RIAs over a long period of time, had 
undergone most phases of regulatory reform.  Although non-OECD countries were, in general, at the 
deregulation phase (i.e., eliminating those types of regulations which were impeding trade or 
investment), they were steadily moving into th e second phase:  regulatory quality and improvement.  
This, she said, is where RIAs become releva nt:  after having "cleaned the swimming pool" 
governments need to focus on the quality of new regu lation (paragraph 50, above).  RIAs were useful 
in this context because it was not always obvious what policies or types of regulations were, for 
example, the least trade restrictiv e in terms of the TBT Agreement. 
                                                      
39 Presentation by Mrs Barbara Fliess (OECD).  G/TBT/W/287 
 Page 23 
 
 
  Figure 10 
 
73. Mrs. Fliess noted that although RIA mechan isms are widespread among OECD countries, 
explicit consideration of trade a nd investment impacts in OECD countries is still not the norm.  An 
exception is Mexico, which has guidelines that make explicit that international trade and 
competitiveness considerations have to be  taken into account; the guidelines include, inter alia , the 
consideration of Mexico's commitme nts under existing trade agreements. 
74. Mrs. Fliess noted among the emerging economies e xplored in an OECD study (Brazil, Russia, 
India, China and South Africa), none of them have a fully-fledged RIA process in place.  Nonetheless, 
all of them have started to implement individual co mponents of RIAs and this is particularly the case 
in the area of technical regulations and standard s.  She said this is probably because technical 
regulations have a direct impact on trade and there is therefore a tangible impetus from the business community.  Also the dynamics created by the TBT and SPS Agreement and the enhanced momentum in the area of good regulatory practice plays a role in this respect.   
75. As developing countries move from deregulation to improving regulatory quality, there is a 
growing need to build political support, address institutional capacity constraints and involve 
concerned constituencies in the administration, as well as the private sector.  Mrs. Fliess noted that in 
many emerging economies regulatory approaches are ad hoc  in nature: i.e., while much is done on an 
informal basis there is often no legal basis for this work.  Thus, there is scope for a more formalized 
RIA process.   
76. Among the emerging economies reviewed by the OECD, South Africa appeared to be the 
most advanced in terms of advoca ting and preparing the introduction of  RIAs.  Mrs. Fliess noted that 
although there is no legislation that requires the use of RIAs in South Africa, many aspects of RIAs 
already exist in the rule-making process.  An example is the way the South Africa Bureau of 
Standards (SABS) operates: when a new regulati on is being proposed SABS undertakes a feasibility 
study to determine the need to regulate and holds pub lic consultations with affected stakeholders.  An 
impact assessment is undertaken, including the following features:  risk assessment, cost/benefit G/TBT/W/287 
Page 24  
 
  analysis, and the consideration of possible regulat ory overlap.  Although this is an example of a 
policy-specific RIA, (in this case targeting techni cal regulations and standards), this work has 
prompted, in 2006, the consideration of a government-wide mechanism.   
77. Mrs. Fliess noted progress in other countries:  China’s Standardization Law requires periodic 
reviews of standards to ensure continuing releva nce; Russia has a law on technical regulation which 
requires a cost-benefit analysis prior to the adoption of new regulation; in Brazil, stakeholder input is 
used as a regulatory quality control in the standard -setting process.  In India, although there is no 
formal or informal practice of assessing the imp act of regulation, India is promoting market 
confidence inter alia  by engaging the private sector through consultations with a goal to shift away 
from government led reforms to private sector led reforms. 
78. Mrs. Fliess stressed that a key challenge is to  move from specific RIAs (for instance those 
used only on technical regulations and standards)  to other policy areas for these are useful as a 
government-wide decision making process.  In whatever area applied, the tools and underlying logic is the same:  define the problem; seek the least burdensome solution; and, enhance transparency and 
private participation.   Essential to this  is enhanced inter-agency co-ordination.
40 
79. Mrs. Fliess noted that in terms of assistance,  the OECD's contribution is the sharing of 
country experiences.  A set of principles on GRP (OECD Guiding Principles for Regulatory Quality and Performance) had been established by the OECD – these are also at the centre of the APEC-OECD Integrated Checklist on Regulatory Reform.
41  She noted that although the OECD recognized 
the capacity constraints in the area of undertaking RIAs in many non-OECD countries, the OECD was 
not in a position to provide technical assistance fo r the implementation of these principles.  In this 
regard, Mr. Santiago dos Santos (European Communities) noted that the European Communities has 
programs in place to support trade partners, including with respect to institution building that could be 
relevant. 
7. Conclusion 
80. The moderator noted that while the session ha d focussed on RIAs it had also served to place 
RIAs in the broader context of regulatory reform .  With the "swimming pool" analogy (Mr. Jacobs) 
and the pyramid diagram (Mrs. Fliess) participants  heard how RIAs serve an important role in 
filtering the flow of new regulations.  RIAs are, essentially, a quality check. He noted that several 
speakers had stressed that the implementation of RIAs is an ongoing process and it is about helping 
decision-makers “think harder” about how to solve a particular problem.  It is also about increasing transparency and making decision-makers accountable. In  application, RIAs are a flexible tool that 
can be made to suit requirements in countries with di fferent levels of developm ent, and that could be 
used in several different areas (of which standa rds was only one).  The importance of awareness 
raising and capacity building was also emphasized by several speakers.   
D. S
ESSION 4 – REGULATORY COOPERATION INITIATIVES  
81. The moderator, Dr. Ana María Vallina (Chile)42 said the session was intended as an 
opportunity to share experiences on regulatory cooperation initiatives between regulators from 
different Members.   She recalled that in its work, the TBT Committee had stressed that cooperation 
between regulators could help achieve a better unde rstanding of different regulatory systems.   
                                                      
40 More information n the OECD’s work on Regulatory Reform can be found at: 
http://www.oecd.org/topic/0,3373,en_2649_37421_1_1_1_1_37421,00.html  
41 Available at http://www.oecd.org/dataoecd/41/9/34989455.pdf . 
42 The Annex to G/TBT/GEN/67/Rev.1 contains brief biographies on speakers and moderators.   G/TBT/W/287 
 Page 25 
 
 
  Moreover, the Committee regularly had heard experi ences in this regard, most recently from Canada 
and Costa Rica.43   
1. The US-EC regulatory cooperation initiative44 
82. Mr. Holland (European Communities) said considering the large amount of trade and 
investment between the United States and the Eu ropean Communities, reducing the costs of such 
trade brought significant returns.  As the US-EC trad e relationship is characterized by relatively low 
tariffs, non-tariff barriers (NTBs) are an increasingly important factor to address. Hence, deeper US-
EC regulatory cooperation is an essential activity to promote more compatible transatlantic regulatory 
approaches, thereby enhancing economic ties.  The objectives of the cooperation include the 
promotion of better qua lity regulation, minimizing unnecessary regulatory divergences, minimizing 
trade frictions and increasing consumer confidence.   
83. Mr. Sanford (United States) noted that the term "regulatory cooperation" is broad in scope.  It 
is an umbrella term that represents different kinds of cooperation activities, including regulator-to-
regulator engagement (most often on prospective regulation) as well as a whole spectrum of activities 
ranging from: ad hoc  informal information exchanges to structured dialogues and even binding 
government agreements (e.g., MRAs).  He said the choice of the appropriate approach depends on 
policy context and objective.  Over the last ten y ears, a variety of policy initiatives which featured 
regulatory cooperation in the area of technical barriers had been undertaken:   
• US-EU MRA (1998)  
• Transatlantic Economic Partnership (1998)  
• Guidelines for US-EU Regulatory Cooperation and Transparency (2002) 
• US-EU Positive Economic Agenda (2002)  
• US-EU Economic Initiative (2005)  
• Framework for Enhancing Transatlan tic Economic Integration (2007) 
• Transatlantic Economic Council (2007) 
84. In terms of where the dialogue is taking pl ace between the European  Communities and the 
United States, there are three main areas to hi ghlight: Regulatory Cooperation Roadmap (sectoral 
dialogues and sector-specific agreements – such as au tos, drugs and medical devices); the US Office 
of Management and Budget (OMB) and European Co mmission dialogue on good regulatory practices 
(dealing with issues such as transparency, impa ct assessments, economic analyses); and, the 
Regulatory Cooperation Forum (senior-level pl atform for cross-cutting issues such as new 
technology, the safety of imported products or policy developments that may impact multiple 
authorities on each side).   Political oversight is provided through the Transa tlantic Economic Council 
(TEC).  At the May 2008 meeting of this group, a number of regulatory cooperation objectives were 
being discussed, including: promoting acceptance of  SDoC for electrical products in the United 
States; joint scientific validation of alternatives to  animal testing; and, mitigating trade impacts 
stemming from implementation of the EU's REACH Regulation. 
                                                      
43  Canada - Costa Rica Co mpetitiveness Development Fund Projects Na tional Quality System  Of Costa Rica, 
Submission by Canada and Costa Ri ca, G/TBT/W/283, 7 November 2007. 
http://www.oecd.org/topic/0,3373,en_2649_37421_1_1_1_1_37421,00.html  
44 Joint presentation by Mr. Jim Sanford (United States) and Mr. Simon Holland (European Communities).  More 
information at:   
http://www.ustr.gov/World_Regions/E urope_Middle_East/Europe/US_EU_Re gulatory_Cooperation/Section_Inde
x.html  
and 
http://ec.europa.eu/enterprise/enterpr ise_policy/inter_rel/eu_us/index_en.htm  . G/TBT/W/287 
Page 26  
 
  85. The speakers underlined that the variety of approaches described above had led to a 
significant expansion of cooperation efforts.  Cu rrently, cooperation is deeper, broader, more 
decentralized and routine, and, in general, more r obust.  However, there is no "one-size-fits-all model" 
(e.g., SDoC might not work in all sectors). Inevitabl y, cooperation entails hard work – but, in turn, the 
reward is more confidence and this is  essential to trade.  It was stressed that practical results are key to 
maintain momentum.  Mr. Holland also emphasized the importance of high-level political 
commitment and stakeholder involvement.  It is not up to regulators to pick their own pet projects: it is those people who have an interest in improve d regulation (e.g. industry, consumers) whose views 
need to be sought.  In terms of lessons lear ned, based on the experience of advancing US-EC 
regulatory dialogues, the Regulatory Cooperation Forum had identified the following "Best 
Cooperative Practices" in 2006: 
• Define scope of cooperation clearly 
• Identify appropriate mechanisms for cooperation 
• Cultivate senior-level suppor t for cooperative activity 
• Provide sufficient resources to support cooperation 
• Provide transparency and opportunity for stakeholder input 
• Promote dialogue between own regulators on best cooperative practices. 
 
86. In response to a question about MRAs in the area of electronic equipment (from Singapore), 
Mr. Sanford noted that there are Annexes under an existing US-EC MRA that deal with telecommunications equipment as well as electromagnetic compatibility (EMC) for, inter alia , 
electrical products.  Electrical safety is an area  of ongoing regulatory cooperation dialogue.  In this 
particular area there is a difference between US and EC systems as the United States has a requirement for third party certification for produ cts used in the workpl ace while the European 
Commission has moved to SDoC.  
87. In response to a question (from Uganda) about  how the United States and the European 
Commission are dealing with counterfeit goods, partic ularly in the area of electronics, Mr. Holland 
noted that a key element of the anti-counterfeit st rategy in the European  Communities is market 
surveillance (to detect counterfeit products on the market) and customs (to detect them in trade). 
Mr. Sanford added that this is a challenging area for both the United States and the European 
Communities and regulatory cooperatio n is one way of addressing the problem but is not the solution 
in and of itself.  The representative of UNECE inform ed participants about relevant work in the area 
of counterfeits and regulat ory cooperation in general.
45  
88. In response to questions (from Uruguay and Para guay) on the focus of US-EC cooperation on 
prospective (future) regulation, Mr. Sanford noted th at the overarching objective of the cooperation is 
to promote less divergent regulation on a case-by -case basis.  There could be instances where 
harmonization, equivalence or mutual recognition is  beyond reach – but, through dialogue, regulators 
on both sides would nevertheless end up bette r informed and these efforts would limit unnecessary  
divergences. Mr. Holland added that discussion about fu ture regulations is the area with the best 
return on investment because such regulations would not have been finalized and there would thus be 
greater scope for alignment.  Work on existing regulations also helps regulators to build up 
relationships that, in turn, meant progress could be achieved faster and more harmoniously in the new 
areas.  
                                                      
45 This information is available on the UNECE website: http://www.unece.org/tra de/wp6/welcome.htm  .  G/TBT/W/287 
 Page 27 
 
 
  2. Israel's Experience in Cooperation between Regulators46 
89. Mr. Deitch noted that as Israel is a relativ ely small country, its industry could not be 
competitive if only based on the domestic market. He said that when developi ng bilateral agreements 
on standardization and conformity assessment with ke y trading partners, Israel advocates a flexible  
approach which is designed, inter alia , to promote cooperation between regulators.  In recent bilateral 
agreements much emphasis was put on establishing "regulatory contact points", usually between 
senior officials in charge of standardization a nd conformity assessment. The agreements contain 
specific articles that define selected senior regulator y officials as contact points.  These officials are 
responsible for the provision of re levant documents, ensuring the smoot h flow of information between 
the parties, providing answers to all reasonable inqui ries and endeavouring to find prompt solutions to 
problems encountered by producers or exporters concerning technical barriers to trade.  
90.  Mr. Deitch emphasized the importance of pers onal relationships between contact points (at 
the top of the pyramid in Figure 11). Such contact s set the scene for informal consultations on a 
variety of issues and cooperation of this natu re could lay the ground for the promotion of 
harmonization between the parties and the reduc tion of unnecessary regulatory differences. Put 
differently, it is important to build informal coope ration between individuals into formal agreements 
between countries. 
Figure 11 
 
 
91. One participant (Benin) asked if the focus was so much on people rather than agencies, was 
there not a concern about consequences of mobility (officials changing positions)?  Mr. Deitch noted 
that the point is to establish, clearly, a contact point – the person  could change but the position  
remains – there would thus always be a direct line to the person responsible for solving a particular 
problem.  
                                                      
46 Presentation by Mr. Gr isha Deitch (Israel). G/TBT/W/287 
Page 28  
 
  3. India and Regulatory Cooperation
47 
92. Mr. Shekhar noted that regulations in India are stipulated through various acts, rules and laws 
by different ministries in India in cognizance of re levant WTO agreements.  In general, regulations 
were developed and enforced in a transparent manner; they were fair and treated all parties equitably.  
Mr. Shekhar also stressed the importance of clear and simple drafting so as to facilitate understanding 
of the regulations.  As well, he said it is importa nt that regulations are flexible to allow for 
amendments and revisions as required.   
93. In India, standards are formulated by the Bureau of Indian Standards (BIS). These are 
primarily voluntary in nature: of more than 18,000 existing standards only 68 standards are subject to 
mandatory certification.  All Indian standards are widely circulated at the draft stage (and drafts are 
available on the BIS website) and the period of commen ts is generally not less than three months.  All 
comments are duly considered.  Mr. Shekhar also de scribed the certification activities of the BIS and 
how notification practices and procedures work in India. 
94. In terms of regulatory cooperation, India has signed MOUs with 15 countries with a view to 
enhancing cooperation in standard ization and conformity assessment as well as facilitating the sharing 
of expertise.  He said an MRA was also establishe d with Sri Lanka on trade facilitation.  Mr. Shekhar 
described the "Indo-US Portal", which is a c ooperation between BIS and the American National 
Standards Institute (ANSI) aimed at: providing a common platform for transparency; facilitating the 
sharing of information on trade issues;  providing mu tual support at international fora; and facilitating 
the harmonization of standards and conformity assessment procedures through increased transparency.  In terms of regional initiatives, the South Asian Regional Standards Association 
(SARSO) was established with the objectives of: increasing cooperation and coordination between 
SAARC countries
48 on standards and conformity assessmen t; developing harmonised standards; 
facilitating intra regional trade; and pr omoting MRAs on conformity assessment. 
4. Conclusion 
95. The moderator said participants had been informed of numerous examples of regulatory 
cooperation activities between Members.  Many fact ors – all regarded as important to fostering 
cooperation between Members – had been highlighted , including: promotion of dialogue (including at 
senior level); acting early (development phase) to a void trade problems before they arise; political 
commitment; and providing resources to support c ooperation.  All speakers had pointed at the 
importance of confidence-building, starti ng at the level of personal contacts.  
  
_________ 
 
  
                                                     
 
47 Presentation by Mr. Chandra Shekhar (India). 
48 Afghanistan, Bangladesh, B hutan, India, Maldives, Nepa l, Pakistan and Sri Lanka.